Clinical Trials List
2023-08-15 - 2028-06-30
Phase II
Not yet recruiting1
Recruiting2
ICD-10C45.9
Mesothelioma, unspecified
ICD-10C79.9
Secondary malignant neoplasm of unspecified site
ICD-10C7A.00
Malignant carcinoid tumor of unspecified site
ICD-10C7A.094
Malignant carcinoid tumor of the foregut NOS
ICD-10C7A.095
Malignant carcinoid tumor of the midgut NOS
ICD-10C7A.096
Malignant carcinoid tumor of the hindgut NOS
ICD-10C7A.1
Malignant poorly differentiated neuroendocrine tumors
ICD-10C7A.8
Other malignant neuroendocrine tumors
ICD-10C7B.00
Secondary carcinoid tumors, unspecified site
ICD-10C80.1
Malignant (primary) neoplasm, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9199.1
Malignant neoplasm of unspecified site (primary) (secondary)
A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Wen-Fang Cheng 無
- 徐偉勛 無
- Wei-Wu Chen 無
- Jih-Hsiang Lee 無
- 李佳真 無
- 沈宜萱 無
- YI-HUA LIAO 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Favezelimab (MK-4280) (Humanized IgG4 mAb) + Pembrolizumab (MK-3475) (Humanized anti-PD-1 mAb)
Dosage Form
Injection
Dosage
MK-4280 20mg/mL and MK-3475 5mg/mL
Endpoints
‧ Objective response (OR)
Inclution Criteria
Cohort A only
Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
Is systemic treatment naïve
Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent
Cohort B only
Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
Has adequately controlled blood pressure without antihypertensive medication
All Cohorts
Agrees to follow contraception guidelines if a participant of childbearing potential
Has a life expectancy >3 years per investigator assessment
Has adequate organ function
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
If positive for hepatitis C, has undetectable viral load at screening
If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy
Exclusion Criteria
All Cohorts
Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
History of allogeneic tissue/solid organ transplant
Cohort A only
Received prior radiotherapy to the index lesion (in-field lesion)
Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible
Cohort B
Has had major surgery within 3 weeks prior to first dose of study interventions
Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
Has urine protein ≥1 g/24 hours
Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
The Estimated Number of Participants
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Taiwan
18 participants
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Global
160 participants
